[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence, double-crossover, fasting bioequivalence study of minocycline hydrochloride capsules in Chinese healthy subjects
主要研究目的:安徽杰玺医药有限公司研制的盐酸米诺环素胶囊(规格: 100mg(按C23H27N3O7计))与Pfizer Japan Inc.持证的盐酸米诺环素胶囊(商品名:MINOMYCIN ®,规格:100 mg(按C23H27N3O7计))空腹单次口服给药在中国健康人群中的生物等效性。
次要研究目的:观察受试制剂和参比制剂在中国健康受试者中的安全性。
[Translation] Primary study objective: To investigate the bioequivalence of minocycline hydrochloride capsules (specification: 100 mg (calculated as C23H27N3O7)) developed by Anhui Jiexi Pharmaceutical Co., Ltd. and minocycline hydrochloride capsules (trade name: MINOMYCIN ®, specification: 100 mg (calculated as C23H27N3O7)) certified by Pfizer Japan Inc. in healthy Chinese subjects after single oral administration on an empty stomach.
Secondary study objective: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.